Spectral CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838101111), received between Apr 12, 2024 and Dec 23, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

11 FDA recall records name this device's identifier, 10 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 21, 2026Open, Classified

   Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.

   Z-0078-2027 · Root cause: Under Investigation by firm · FDA record ↗

2. Aug 18, 2026Open, Classified

   The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.

   Z-3155-2026 · Root cause: Radiation Control for Health and Safety Act · FDA record ↗

3. Jan 7, 2026Open, Classified

   As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

   Z-1317-2026 · Root cause: Process change control · FDA record ↗

4. May 29, 2025Open, Classified

   Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.

   Z-2034-2025 · Root cause: Under Investigation by firm · FDA record ↗

5. Nov 16, 2024Open, Classified

   Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.

   Z-0583-2025 · Root cause: Under Investigation by firm · FDA record ↗

6. Mar 29, 2024Open, Classified

   Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.

   Z-1756-2024 · Root cause: Under Investigation by firm · FDA record ↗

7. Dec 13, 2023Open, Classified

   A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

   Z-1055-2024 · Root cause: Under Investigation by firm · FDA record ↗

8. Nov 30, 2023Open, Classified

   Multiple software issues that affect device functionality.

   Z-0725-2024 · Root cause: Software design · FDA record ↗

9. Mar 17, 2023Open, Classified

   Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.

   Z-1584-2023 · Root cause: Under Investigation by firm · FDA record ↗

10. Jun 8, 2021Terminated

    When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

    Z-2318-2021 · Root cause: Software design · FDA record ↗

11. May 1, 2021Open, Classified

    Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

    Z-1986-2021 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Break; Break

  ON 27-NOV-2025, A FIELD SERVICE ENGINEER (FSE) REPORTED THAT DAMAGE TO A TORQUE SEAL DURING PLANNED MAINTENANCE (PM) ON A SPECTRAL CT 7500 SYSTEM ((B)(6) PRODUCT NUMBER 72833) AT ASAHICHUO GENERAL HOSPITAL IN JAPAN. THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME AND THERE WAS NO HARM TO THE USER, A PATIENT OR BYSTANDERS. DURING INSPECTION, 13 OF THE 15 SCREWS INSPECTED WERE FOUND TO BE CORRECTLY TORQUED TO DESIGN SPECIFICATION. ENGINEERING FOUND THE REMAINING 2 SCREW HEADS WERE UNDER TORQUED (12NM), MOVED APPROXIMATELY 20-30 DEGREES AND WERE NOT CORRECTLY TIGHTENED TO DESIGN TORQUE. THE SCREWS WERE CORRECTED BY RE-APPLYING THE CORRECT DESIGN TORQUE DURING THE TORQUE CHECK PROCESS. AS A RESULT, AN ISSUE IMPACT ASSESSMENT WAS COMPLETED ON 10-DEC-2025 TO ASSESS THE RISK FOR THIS ISSUE AND INDICATED A REMOTE PROBABILITY OF RESULTING IN SERIOUS ADVERSE HEALTH CONSEQUENCES BUT NOT LIKELY TO RESULT IN MEDICALLY REVERSIBLE OR TRANSIENT ADVERSE HEALTH CONSEQUENCES. PHILIPS HAS STARTED AN INVESTIGATION INTO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879398 ↗
• MalfunctionDec 23, 2025Break; Break

  ON (B)(6) 2025 A CUSTOMER AT (B)(6) REPORTED A KNOCKING NOISE AND THE GANTRY WAS WOBBLING ON A SPECTRAL CT 7500 SYSTEM (SN (B)(6), PRODUCT NUMBER 728333). THE SYSTEM WAS IN USE AT THE TIME OF THE INITIAL REPORT BY THE USER. THERE WAS NO HARM TO THE USER, PATIENT OR BYSTANDER AS A RESULT OF THIS ISSUE. THE FSE WAS ONSITE TO INVESTIGATE AND REPORTED THE FOLLOWING ISSUE: WHILE INSPECTING THE GANTRY PLATE, THE ENGINEER FOUND BROKEN SCREW HEADS IN THE BOTTOM OF THE GANTRY. THE SCREW HEADS WERE BROKEN OFF FROM THE SCREWS USED TO ATTACH THE BEARING RING TO THE BACK PLATE (BEARING RING AND BACK PLATE ARE PART OF ASSEMBLY 459801335243 ROTOR ASSEMBLY-FABRICATION). WHILE INSPECTING THE REMAINING ACCESSIBLE BOLTS, THE FSE FOUND ADDITIONAL BROKEN OR PARTIALLY BROKEN SCREWS AND THE REMAINING SCREWS WERE NOT TORQUED TO THE REQUIRED 12NM. THE FSE REMOVED THE SCREWS AND THE USED LOCTITE FROM THE SCREW HOLE. THERE WAS A REQUEST MADE TO KEEP ALL BROKEN OR DAMAGED PARTS FOR FURTHER INVESTIGATION, AND THE SYSTEM WAS REMOVED FROM SERVICE UNTIL A REPLACEMENT COULD BE SUPPLIED TO THE CUSTOMER. DURING THE ENGINEERING INVESTIGATION, THEY FOUND 11 BROKEN SCREWS, 2 ALMOST BROKEN SCREWS, AND 19 THAT WERE NOT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879396 ↗
• MalfunctionApr 12, 2024Fire; Fire

  DURING SYSTEM INSTALLATION, A FIRE OCCURRED IN THE POWER DISTRIBUTION UNIT ON THE AC/DC CONVERTER. THERE WERE VISIBLE FLAMES AND SMOKE; AN EXTINGUISHER WAS USED ON THE FIRE. THE SITE'S FIRE ALARMS WERE NOT TRIGGERED, AND THE FIRE DEPARTMENT WAS NOT DISPATCHED. THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME. THERE WAS NO HARM TO THE SERVICE PERSONNEL OR ANY BYSTANDER. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095238 ↗